Comparative Evaluation of Ringer Lactate Infusion of National and Multinational Brand available in Nowshehra, Pakistan

Abstract

Ringer lactate (RL) solution is a widely used intravenous fluid in medical practice for rehydration and electrolyte balance. In Pakistan, both local and multinational brands of RL infusion are available, raising questions about their comparative quality and efficacy. This study aims to evaluate the physicochemical properties of various local RL brands and compare them with a renowned multinational brand. In this study we took five local and two multinational brand of ringer lactate infusion. This study was carried out in laboratory of JHK Pharma Akorra Khattak, Nowshera. The parameters assessed include pH, osmolarity, sterility, and concentration of key electrolytes, particulate matter per ml, assay, LAL test and physical inspection. All seven brands were checked for clarity, color, and odor and found them clear, colorless and odorless which were according to standard specifications. The Identification test was positive for Lactate, Sodium, Chloride, Potassium and Calcium in all brands and the results complied with standard specifications. pH of each brand was checked and was within the specified range (6.0-7.5). The result showed compliance for each brand for particulate matter per ml which is specified as 10 microns particles should not be more than 25 and 25 microns should not be more than 3. The result of the quality test performed for the assay of total chloride was found to be within the specified range given by USP (97-103%). The result of the quality test performed for the assay of potassium chloride was found to be within the specified range given by USP (95-105%) except brand F which was found to be less than specified range. The tests were performed for the assay of calcium chloride; the results obtained were within the range specified by USP (95-105%). The result of the quality test performed for the assay of sodium lactate was found to be within the specified range given by USP (97-103%). For the purpose of assay, flame spectrophotometer was used to find out the concentration of metallic ions like sodium, potassium and calcium. The specified range for potassium is 3.6-----4.4mM/L, calcium is 1.22----1.49mM/L, and sodium is 124-----136mM/L. The result given by flame spectrophotometer was within the specified range mentioned above for each brand of RL infusions. The LAL and sterility test was also passed by each brand.